UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF NEW YORK
October 3, 1975
ELIZABETH DALEY, M.D., Plaintiff,
CASPAR W. WEINBERGER, Secretary of Health, Education and Welfare, ALEXANDER M. SCHMIDT, M.D., Commissioner of the Food and Drug Administration, CLIFFORD G. SHANE, Regional Director of the Food and Drug Administration, TERRY MUSSON, ALLEN R. HALPER, JOHN E. KLEMMER and THOMAS D. GARDINE, Employees of the Food and Drug Administration, Defendants
The opinion of the court was delivered by: NEAHER
MEMORANDUM AND ORDER
NEAHER, District Judge.
Plaintiff Elizabeth Daley, a licensed physician practicing in New York City, brought this action under 28 U.S.C. §§ 1331 and 1337 seeking declaratory and injunctive relief aimed at preventing defendants (hereinafter "FDA") from any further attempts to conduct an inspection of her office. The case is now before the court on FDA's motion to dismiss the complaint or in the alternative for summary judgment. Rules 12(b)(6) and 56, F.R.Civ.P.
In the course of plaintiff's practice it appears that she prescribes various drugs, including prednisone, testosterone, estradiol and combinations thereof, for patients suffering from rheumatic diseases, principally rheumatoid arthritis. She alleges that on or about February 10, 1975, defendant Allen R. Halper, an FDA investigator, visited her office in New York City, interrogated a registered nurse in her employ and served a Notice of Inspection pursuant to Section 704(a) of the Food, Drug and Cosmetic Act, 21 U.S.C. § 374(a) ("the Act").
On or about February 27, 1975, two other FDA investigators, defendants John E. Klemmer and Thomas D. Gardine, appeared at plaintiff's office, interrogated the registered nurse and served a second Notice of Inspection.
Plaintiff believes that she is being investigated concerning a drug called Liefcort. Although she claims that FDA lacks jurisdiction under the Act
to investigate or inspect either her practice or the treatment she prescribes for her patients, she asserts her willingness to discuss with FDA officials, through her attorney, details of medications which she prepares, prescribes and administers to her patients.
FDA acknowledges that its desire to inspect plaintiff's premises stems from a belief that in the course of plaintiff's practice she may be distributing Liefcort, a drug not approved by FDA. Liefcort, which is apparently used outside this country in the treatment of arthritis, is believed to consist of prednisone, testosterone and estradiol, in proportions known only to its discoverer, the late Dr. Robert Liefmann. FDA believes that some of it may have been shipped into the country and found its way into plaintiff's offices.
Essentially four grounds are relied on in support of FDA's motion to dismiss or for summary judgment: (1) there is no justiciable controversy before the court; (2) FDA, an agency of the United States, has not consented to the suit and therefore it is barred by the doctrine of sovereign immunity; (3) there is an adequate remedy at law; and (4) FDA does have the statutory authority to investigate plaintiff's offices.
The absence of a justiciable controversy is premised on a lack of ripeness, a question necessarily involving a discretionary determination as to whether a particular controversy is appropriate for judicial resolution. In situations, such as this, where a pre-enforcement attack is made on the validity of administrative action, the Court, in the drug trilogy cases Abbott Laboratories v. Gardner, 387 U.S. 136, 18 L. Ed. 2d 681, 87 S. Ct. 1507 (1967); Toilet Goods Ass'n. v. Gardner, 387 U.S. 158, 18 L. Ed. 2d 697, 87 S. Ct. 1520 (1967); Gardner v. Toilet Goods Ass'n., 387 U.S. 167, 18 L. Ed. 2d 704, 87 S. Ct. 1526 (1967), has established guidelines for ascertaining the appropriateness of judicial intervention.
The test to be applied is twofold in nature and involves an evaluation of "both the fitness of the issues for judicial decision and the hardship to the parties of withholding court consideration." Abbott, supra, 387 U.S. at 149. The first part of the test, i.e., the fitness of the issues for resolution, itself consists of two parts -- whether the issues raised were purely legal in nature and whether the challenged agency action was final. Id.
In Abbott, supra, the plaintiffs had challenged the authority of the Secretary of Health, Education and Welfare to promulgate certain regulations, which had already been the subject of hearings and had been published in final form with immediate compliance expected. Applying the two-part test, the Court noted that the tendered issues were purely legal and the agency action was in every respect final, not tentative, and not the action of a subordinate official. Abbott Laboratories, supra, 387 U.S. at 151. Additionally, the challenged regulations would have "a direct effect on the day-to-day business of all prescription drug companies . . ." (387 U.S. at 152), and therefore withholding judicial consideration would necessitate considerable hardship. Under those circumstances, the Court departed from the otherwise settled rule that courts are to avoid "entangling themselves in abstract disagreements over administrative policies" and that administrative agencies are entitled to be free "from judicial interference until an administrative decision has been formalized and its effects felt in a concrete way by the challenging parties." Abbott Laboratories, supra, 387 U.S. at 148-49.
In this case, the only action taken by FDA has been to cause two notices of inspection to be served and to question plaintiff's nurse. The notices merely recite various statutory provisions authorizing FDA inspections without specifying the purpose of the inspection or what FDA expects to find on the premises it seeks to enter.
Applying the Abbott Laboratories test to these facts, the court is of opinion that discretion should not be exercised in favor of retaining jurisdiction. While the issue raised appears to be a purely legal one, i.e., the FDA's statutory authority to inspect a physician's office, there is here no final agency action whose legality the court may pass upon. Although FDA agents made two visits to plaintiff's office, no inspection was in fact conducted. The court is reluctant to anticipate what future action, if any, FDA may decide to take.
In American Dietaids Co., Inc. v. Celebrezze, 317 F.2d 658 (2 Cir. 1963), the court affirmed the dismissal of an action brought to enjoin FDA inspectors from using concealed tape recorders during future inspections of a plaintiff's premises, saying:
"There is no ground in such a single past incident for declaratory relief against possible future inspections. There is no actual controversy now existing on which to found declaratory relief. . . . 'Especially where governmental action is involved, courts should not intervene unless the need for equitable relief is clear, not remote or speculative.' [Quoting from Eccles v. Peoples Bank of Lakewood Village, Cal., 333 U.S. 426, 431, 68 S. Ct. 641, 644, 92 L. Ed. 784.]" 317 F.2d at 660.
That language is apposite here.
This case is also distinguishable from Abbott and Gardner on the question of the hardship of withholding judicial consideration at this time. In those cases the challenged regulations required the plaintiffs to take positive action which would have had "a direct effect on [their] day-to-day business . . . ." Here, no action on plaintiff's part is required -- the ball, so to speak, is in FDA's court.
If FDA decides to pursue the matter further, there are two courses of action available. First, if FDA desires to enforce its claimed right of inspection under § 374, it will have to seek the court's aid under § 332, which grants the district courts jurisdiction to enjoin violations of § 331. Subdivision (f) of § 331 prohibits "[the] refusal to permit entry or inspection as authorized by § 374 . . .." If relief were granted under § 332 the occupant (plaintiff here) would be enjoined from refusing entry to FDA inspectors. Cf. Brennan v. Buckeye Industries, Inc., 374 F. Supp. 1350 (S.D. Ga. 1974). In such a proceeding plaintiff would have the opportunity to explain to the court her reasons for denying entry to the FDA inspectors and the legal issue raised could then be properly decided. See, e.g., FTC v. Simeon Management Corporation, 391 F. Supp. 697, 1975 Trade Cases P60,223 (N.D. Cal. 1975).
Second, FDA could institute criminal proceedings against plaintiff under 21 U.S.C. § 333(a),
in which event she could raise as a defense FDA's lack of authority to inspect her office. See, e.g., United States v. Thriftimart, Inc., 429 F.2d 1006 (9 Cir.), cert. denied, 400 U.S. 926, 27 L. Ed. 2d 185, 91 S. Ct. 188 (1970).
Plaintiff urges that she should not be required to test the legality of FDA's right to inspect her office in a criminal proceeding, on pain of conviction should she lose. Her fear of prosecution, however, is not a sufficient predicate for this court to retain jurisdiction. Here, there is no indication that the government intends to prosecute plaintiff either for her past two refusals to permit entry or for any future refusals -- unlike the situation in Doe v. Bolton, 410 U.S. 179, 93 S. Ct. 739, 35 L. Ed. 2d 201 (1973), where physicians challenged the constitutionality of a Georgia abortion statute under whose predecessors doctors were actually prosecuted. Cf. Laird v. Tatum, 408 U.S. 1, 13, 92 S. Ct. 2318, 2325, 33 L. Ed. 2d 154 (1972),
and Socialist Workers Party v. Attorney General of the United States, 510 F.2d 253 (2 Cir. 1974).
Moreover, absent compelling circumstances, such as presented in the Doe case, there is no basis for a court to issue a judgment declaring in advance of a criminal prosecution that acts already committed, or even to be committed in the future, are or are not unlawful. Cf. Ewing v. Mytinger & Casselberry, 339 U.S. 594, 599, 94 L. Ed. 1088, 70 S. Ct. 870 (1950).
Finally, in construing statutes providing criminal penalties for individuals who refuse to honor administrative summonses, the courts have held in parallel situations that good faith noncompliance is not subject to prosecution. See Reisman v. Caplin, 375 U.S. 440, 446-49, 11 L. Ed. 2d 459, 84 S. Ct. 508 (1964) (good faith refusal to honor an internal revenue service summons would be a defense to a prosecution under 26 U.S.C. § 7210).
Similarly, in Anheuser-Busch, Inc. v. Federal Trade Commission, 359 F.2d 487 (8 Cir. 1966) (Blackmun, J.), the court held that § 10 of the Federal Trade Commission Act, 15 U.S.C. § 50, which makes it an offense to refuse "to answer any lawful inquiry . . . if in [one's] power to do so, in obedience to the subpoena or lawful requirement of the Commission . . .", does not authorize criminal prosecution "where the challenge to the subpoena is in good faith." 359 F.2d at 490. See also Federal Power Commission v. Metropolitan Edison Co., 304 U.S. 375, 386-87, 82 L. Ed. 1408, 58 S. Ct. 963 (1938).
The court concludes that a controversy sufficiently ripe for adjudication does not presently exist between the parties. Defendants' motion for summary judgment dismissing the complaint is therefore granted.
The Clerk of the Court is directed to enter judgment dismissing the complaint.
Edward R. Neaher / U.S.D.J.
Dated: Brooklyn, New York October 2, 1975